Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Fluorometric Method, Cpk Or Isoenzymes
510(k) Number K840549
Device Name CK-B RIA KIT
Applicant
Diagnostic Systems Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Diagnostic Systems Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1215
Classification Product Code
JHX  
Date Received02/08/1984
Decision Date 05/07/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-